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Functional Remediation for Bipolar Disorder

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01370668
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Hospital Clinic of Barcelona
Benito Menni
University of Valencia
Hospital Universitari de Bellvitge
Universidad de Oviedo
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital General Universitario Gregorio Marañon
Hospital Santiago Apóstol de Vitoria
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Information provided by:
Centro de Investigación Biomédica en Red de Salud Mental
  Purpose
Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of the population. Recent research point at the relevance and persistence of cognitive dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment has been classically associated with schizophrenia and not bipolar disorder. Current findings suggest that some intervention is needed in order to improve not only affective symptoms but also cognitive dysfunctions, so that patients could benefit from cognitive remediation techniques to improve cognitive impairment and the functional outcome. There is no previous research on the efficacy of cognitive remediation programs on bipolar disorder.

Condition Intervention
Bipolar Disorder Behavioral: Functional remediation Behavioral: Psychoeducation Behavioral: Treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparative Efficacy of Two Psychosocial Strategies of Intervention (Neurocognitive vs Psychoeducative) as add-on Therapy Versus Treatment as Usual in Bipolar Disorder

Resource links provided by NLM:


Further study details as provided by Centro de Investigación Biomédica en Red de Salud Mental:

Primary Outcome Measures:
  • Functional Assessment Short Test (FAST) [ Time Frame: Baseline ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.

  • Functional Assessment Short Test (FAST) [ Time Frame: 6 months ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.

  • Functional Assessment Short Test (FAST) [ Time Frame: 12 months ]
    The FAST is a valid and reliable instrument, easy to apply which requires a short period of time to administer. Evaluates functioning taking into account the last 15 days. It was developed for the clinical evaluation of the main difficulties presented by psychiatric patients, and has been validated in several languages for patients with bipolar disorder. The FAST scale consists of 24 items which allow the assessment of six specific areas of functioning: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships and leisure time.


Enrollment: 198
Study Start Date: January 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Functional remediation

Patients assigned to the experimental treatment will receive standard psychiatric care and will be enrolled in the neurocognitive intervention program composed of 21 sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning.

The program will be performed in an 8-to-10 patient group conducted by 2 experienced neuropsychologists. with previous experience with bipolar patients (at least 3 years) and specific training on patients' group management.

Behavioral: Functional remediation

The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning.

The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management.

Active Comparator: Psychoeducation
The group psychoeducation is a tested (Colom et al, 2003) and manualized intervention (Vieta and Colom, 2006) consisting on 21 sessions of 90 minutes, aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences and lifestyle regularity. The program will be performed in an 8-10 patient group conducted by 2 experienced psychologists with previous experience with bipolar patients and specific training on patients' group management. The structure of each session consists of a 30 to 40 minute speech on the topic of the day, followed by an exercise related to the issue (eg. drawing a life chart, writing a list of potential triggering factors) and a discussion.
Behavioral: Psychoeducation
Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.
Active Comparator: Treatment as Usual
This arm will not receive any sort of add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
Behavioral: Treatment as usual
The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.

Detailed Description:
The method consists of a randomized clinical trial with 3 arms: 1) one group (n=66) will receive a cognitive rehabilitation program + pharmacological treatment, 2) another group (n=66) will receive a psychoeducation program + pharmacological treatment, and 3) a control group (n=66) will only receive pharmacological treatment. A psychopathological, neuropsychological and functional assessment will be administered pre and post-intervention and a 12-month follow-up to assess the long term effects of the intervention.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Outpatients
  • Diagnosis of bipolar disorder type I or II, according to DSM-IV-TR 4ª Ed criteria
  • Adult patients, aged between 18 and 55 years old
  • Euthymic (YMRS < 6, HDRS < 8) for at least three months prior to study entry.
  • Signed inform consent
  • Severe or moderate functional impairment (FAST > 18)

Exclusion Criteria:

  • IQ < 85
  • Neurological illness
  • Present diagnosis of substance abuse or dependence according to DSM-IV criteria the last three months
  • Significant medical illness considered as severe by the study that may interfere with assessments
  • having been enrolled in any kind of cognitive rehabilitation intervention the last two years
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01370668


Sponsors and Collaborators
Centro de Investigación Biomédica en Red de Salud Mental
Hospital Clinic of Barcelona
Benito Menni
University of Valencia
Hospital Universitari de Bellvitge
Universidad de Oviedo
Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
Hospital General Universitario Gregorio Marañon
Hospital Santiago Apóstol de Vitoria
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
Principal Investigator: Eduard Vieta, MD, PhD Centro de Investigación Biomédica en Red de Salud Mental
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Eduard Vieta, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01370668     History of Changes
Other Study ID Numbers: PI08/90094
PI080180 ( Other Grant/Funding Number: Fondo Investigaciones Sanitarias )
First Submitted: March 10, 2011
First Posted: June 10, 2011
Last Update Posted: June 10, 2011
Last Verified: June 2011

Keywords provided by Centro de Investigación Biomédica en Red de Salud Mental:
functional remediation
psychoeducation
neurocognition

Additional relevant MeSH terms:
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders